In what may be a shocking report, an Aug. 22 article describes how medical manufacturers actually rely on medical professionals to alert them to problems with their devices. Then, once the physicians know of defects, the medical device managers rely on those physicians to screen the devices out because of defects.
What should happen? A device that causes patient injuries or that has defects should be recalled, but that doesn’t always happen. Results from a behavioral study from Indiana University and the University of Minnesota claim that issuing a recall could affect an operation manager’s career, so many rely on medical providers to screen out the devices and stop using them on patients.
They then don’t issue a recall for the primary reason that the device is no longer a danger to a patient. However, that may not always be the reality. If a medical provider doesn’t know of the risks, then a device could be used in a patient and lead to a patient’s injuries or death.
The study caught the eye of the Food and Drug Administration (FDA) because it wishes to see if it can make changes to better oversee the quality of medical-device products. By the sound of this report, many managers wait until they know the details of why a device has problems instead of issuing a recall right away. That could mean that patients are placed in danger longer, and that’s something that the FDA could adjust for. In the right circumstances, devices with known defects would be removed from circulation immediately to prevent patient injuries.